Adipose-derived Stem Cells (ADSCs) for Knee Osteoarthritis
Study Details
Study Description
Brief Summary
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To assess the safety of allogeneic injection of expanded ADSCs to patients with knee osteoarthritis
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To assess the efficacy of allogeneic injection of expanded ADSCs to patients with knee osteoarthritis
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Elixcyte 8mL ADSC 6.4*10^7 cells, allogeneic injection, one time injection on Day 1 |
Biological: Elixcyte 8 ml
ADSC 6.4*10^7 cells, allogeneic injection
|
| Active Comparator: Hya Joint Plus Hya Joint Plus synovial fluid supplement 3mL, SciVision Biotech Inc., one time injection on Day 1 |
Device: Hya Joint Plus
Hya Joint Plus synovial fluid supplement 3mL, SciVision Biotech Inc.
|
| Experimental: Elixcyte 4mL ADSC 3.2*10^7 cells, allogeneic injection, one time injection on Day 1 |
Biological: Elixcyte 4 ml
ADSC 3.2*10^7 cells, allogeneic injection
|
| Experimental: Elixcyte 2mL ADSC 1.6*10^7 cells, allogeneic injection, one time injection on Day 1 |
Biological: Elixcyte 2 ml
ADSC 1.6*10^7 cells, allogeneic injection
|
Outcome Measures
Primary Outcome Measures
- Changes from baseline to post-treatment visit of WOMAC pain score at week 24 after treatment [Weeks 0, 24]
- Incidence of adverse events (AEs) and serious adverse events (SAEs) [Week 48]
Secondary Outcome Measures
- Changes from baseline to post-treatment visits of Visual Analogue Scale (VAS) to measure Pain Levels [Weeks 0, 2, 4, 12, 24, 36, 48]
- Changes from baseline to post-treatment visits of scores of sections in Knee Society Clinical Rating System (KSCRS) Score [Weeks 0, 2, 4, 12, 24, 36, 48]
- Changes from baseline to post-treatment visits of MRI examination results [Weeks 0, 24, 48, 72, 96]
- Changes from baseline to post-treatment visits of total score, and sub-scores of all sections in WOMAC [Weeks 0, 2, 4, 12, 36, 48]
- Total acetaminophen consumption amount during the first 48 weeks and week 48 to week 96 [Week 0, 2, 4, 12, 24, 48, 96]
- Total non-steroidal anti-inflammatory drug (NSAID) consumption amount during the first 48 weeks and week 48 to week 96 [Weeks 0, 2, 4, 12, 24]
- Time to subject first time consumes acetaminophen [Weeks 0, 2, 4, 12, 24]
- Time to subject first time consumes non-steroidal anti-inflammatory drug (NSAID) [Weeks 0, 2, 4, 12, 24]
- Number of patients with clinically abnormal laboratory values and/or adverse events that are related to treatment [Weeks 0, 2, 4, 12, 24, 36, 48, 72, 96]
- Number of patients with clinically abnormal vital signs and/or adverse events that are related to treatment [Weeks 0, 2, 4, 12, 24, 36, 48, 72, 96]
- Changes from baseline to week 96 visit in cartilage thickness in the total femorotibial joint by centralized (independent) imaging interpretation. [Weeks 0, 24, 48, 72, 96]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged 40-80 years (inclusive)
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Kellgren-Lawrence grading I-III, as determined by American College of Rheumatology (ACR) criteria for osteoarthritis of the knee
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Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score of 7-17 in the study knee even if treated with chronic doses of non steroidal anti-inflammatory drugs
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Having provided informed consent
Exclusion Criteria:
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With previous surgery of articular fracture, ligament reconstruction, meniscal reconstruction, and knee arthroplasty on the target knee joint
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With previous intra-articular intervention on the target knee joint within past 3 months (e.g. steroid, anaesthetic, sodium hyaluronate)
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Known or suspected infection of the target knee joint
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Ascertained hypersensitivity to any component used in the study
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Administered with systemic anti-inflammatory drugs (e.g. non-steroidal anti-inflammatory drug or steroid ) or topical anti-inflammatory drugs on target knee within 7 days prior to administration in the study
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With serious prior or ongoing medical conditions (e.g. concomitant illness such as cardiovascular (e.g. New York Heart Association grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition, alcoholism, drug abuse), medical history, physical findings, , or laboratory abnormality that in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the patient
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With any evidence of malignant disease with life expectancy of less than 1 year
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Pregnant or lactating women or planning to be pregnant during the study period
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With body mass index (BMI) greater or equal to 35 kg/m2
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With joint diseases except knee osteoarthritis considered by investigator not eligible to enter the study
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With known history of human immunodeficiency virus (HIV) infection.
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Judged to be not applicable to this study by investigator such as difficulty of follow-up observation
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With any other serious diseases/medical history considered by the investigator not in the condition to enter the trial
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Having participated other investigational study within 4 weeks of entering this study
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With known history of claustrophobia
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Having any existing active/inactive implanted medical devices, such as cardiac pacemaker, cochlear, intracranial vascular clips or neurostimulator, etc...
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Having any existing metallic intraocular foreign body
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Taipei Veterans General Hospital | Taipei | Taiwan | 112 | |
| 2 | Chang Gung Memorial Hospital Linkou | Taoyuan City | Taiwan | 333 |
Sponsors and Collaborators
- UnicoCell Biomed CO. LTD
- A2 Healthcare Taiwan Corporation
Investigators
- Principal Investigator: Yu-Han Chang, MD, Chang Gung Memorial Hospital
- Principal Investigator: Cheng-Fong Chen, MD, Taipei Veterans General Hospital, Taiwan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CT21